Label: DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH- benzocaine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 4, 2013

If you are a consumer or patient please visit this version.

  • Outer carton labeling

    outer carton

    Benzocaine 20%

    Oral Pain Reliever

    Use for the temporary relief of pain due to: • toothaches  • canker sores  • cold sores  • sore gums

    Warnings

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

    When using this product  • avoid contact with the eyes  • do not exceed recommended dosage  • do not use for more than 7 days unless directe

    Stop use and ask a dentist or doctor if  swelling, rash or fever develops  • irritation, pain or redness persists or worsens  • symptoms do not improve in 7 days  

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

    Directions  • dip applicator into liquid

    Adults and children 2 years of age and older   Apply a small amount of product to the affected area.  Use up to 4 times daily or as directed by a dentist or doctor.

    Children under 12 years of age   Should be supervised in the use of this product.

    Children under 2 years of age   Ask a dentist or doctor.

    Other information  • do not use if safety seal on carton is broken  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted  • do not use continuously 

    Inactive ingredients:  Carbowax 400, Peppermint Oil, Spearmint Oil, Sucralose

    Questions or comments? Call us  1-800-952-5080 M-F 8am - 5pm EST of visit our website www.dentek.com

  • inner vial label

    inner vial label

  • INGREDIENTS AND APPEARANCE
    DENTEK INSTANT PAIN RELIEF  MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Coloryellow (colorless to light yellow liquid) Score    
    ShapeSize
    FlavorPEPPERMINT, SPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60630-077-021 in 1 CARTON
    1NDC:60630-077-013.7 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/01/2014
    Labeler - DenTek Oral Care. Inc. (153818646)
    Registrant - DenTek Oral Care, Inc. (153818646)